1. Field of the Invention
This invention relates to methods and apparatus for decontaminating enclosed spaces such as hospital wards and clean rooms in which a manufacturing or other processes take place in sterile conditions.
2. Present State of the Art
Vaporised aqueous solution of hydrogen peroxide has been used to decontaminate the internal surfaces of enclosures used for aseptic processing in the pharmaceutical industry since about 1990, but it has always been difficult to use the same technology to decontaminate larger enclosed volumes such as rooms.
The conventional apparatus for decontaminating enclosures comprises a gas generator in a closed circuit including the enclosure such as described in U.S. Pat. No. 5,173,258. In this design the hydrogen peroxide and water vapours are produced by flash evaporation of an aqueous solution into a heated air stream, which then carried the gas to the space to be decontaminated. The air and mixture of gases then mixes with the air inside the chamber before being returned to the gas generator, where the gas is decomposed, dried, heated and more liquid is flash evaporated and the air mixture is returned to the chamber.
The processes performed on the returned gas are complex, and include the steps of decomposing the gas, drying and re-heating. This complete process was considered necessary because it was understood that the hydrogen peroxide gas decomposed according to a half-life rule and hence to maintain an adequate concentration inside the chamber a circulating system that decomposed the gas was thought to be necessary. Recent work by Watling, ISPE Conference Zurich, September 1999 has shown that the gas does not decompose but is stable. It is therefore not necessary to remove the returning gas from the chamber.
S.S. Block reports in the 5th Edition of Disinfection, Sterilisation and Preservation page 189 that a 3% hydrogen peroxide aqueous solution gives a log 8 reduction of Staphylococcus aureus in under 20 minutes. A slower rate of deactivation has been found in experimental work when exposing Staphylococcus aureus to gas generated from 35% solution, when the process was operated at a temperature below the dew point thus causing condensation. Under these gassing conditions the first droplets of dew form on the organism at a much higher concentration than that of the original liquid, typically about 65% w/w, the exact value depending on the moisture content of the carrier gas.
As stated above, in the conventional system the air in the chamber to be decontaminated is dried prior to injecting the decontaminating gas. This is done either to allow a high level of gas concentration to be achieved before the onset of condensation, or to operate the process avoiding condensation maintaining the gas in a dry state. The vapour pressure equations for hydrogen peroxide and water may be used to calculate the concentration of the hydrogen peroxide and water vapour that will cause condensation and hence may be used either to avoid the conditions that will cause the onset of condensation or to calculate the concentration of any condensate that may be formed as a result of passing the flash evaporated vapours into the sealed enclosure. If the RH in the chamber is high the condensation will form quickly but as a relatively weak solution. Evaporating 35% w/w hydrogen peroxide into a chamber at 20° C. and 85% RH will cause the condensate to form at in excess of 6% w/w, although the concentration of the vapour will be about 120 ppm. It is well known that 6% hydrogen peroxide is active against microorganisms and will cause bio-deactivation of surfaces. If it is intended to operate a process where condensation is formed it is therefore not necessary to reduce the humidity in the chamber under normal operating conditions as the RH will be less than 85% and hence the condensation will form at a concentration greater than 6%. The same is not true when operating a process that is intended to avoid condensation, in such a process it is essential to ensure that the moisture content of the air inside the enclosed space at the start of the process is low.
It is believed that the difference between the liquid process as reported by Block and a gaseous dew process is the rate of delivery of the hydrogen peroxide condensation. It follows that using a standard recirculating gas generator placed outside the space to be bio-decontaminated; there may not be an adequate evaporation capacity to achieve a sufficiently high condensation rate to deactivate the organism inside the chamber. The deactivation process may be enhanced by the use of mixtures of chemicals but the principal of the rate of delivery still remains. Whilst for a dry gas process the rate of delivery of hydrogen peroxide and water vapour are not so critical it is still important to evaporate the liquid as fast as is practical as this will shorten the time required to raise the gas concentration and achieve a satisfactory bio-decontamination.
An analysis of the equations governing the vapour pressure of water and hydrogen peroxide by Watling et al and published in the PDA Journal of Science and Technology November/December 2002 vol 56, No 6 291-299, shows that the gas concentration inside a chamber may be raised to the dew point by passing flash evaporated vapour into the sealed enclosure, but as soon as the dew point is reached condensation will form at a higher concentration than the evaporated liquid thus reducing the gas concentration. The gas concentration will continue to fall as more liquid is evaporated until the equilibrium vapour pressure for the evaporated liquid is reached at the temperature of the chamber.
There are two views about the mechanisms involved in the bio-decontamination using hydrogen peroxide and water vapour. The first is that it is important to ensure that the gas remains in the dry state and the second that condensation is essential. It has been well established that dry hydrogen peroxide gas at elevated temperatures will bio-deactivate micro-organisms, and the same dry process has been shown to work at room temperatures. The condensation process in which the gas concentration is raised to the dew point and condensation is allowed to form appears to be faster at room temperatures.